Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma

December 28, 2024 updated by: Qingqing Cai, Sun Yat-sen University

Efficacy and Safety of Zuberitamab and Bendamustine Combination Treatment Followed by Monotherapy Maintenance in Treatment-naïve Follicular Lymphoma: an Open-label, Prospective, Multicenter, Single-arm Phase II Clinical Study

This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntary signing of informed consent.
  2. Age ≥ 18 years, no gender restriction.
  3. Histologically confirmed follicular lymphoma (grades 1-3a), CD20 positive by immunohistochemistry.
  4. No prior systemic treatment for FL.
  5. Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm).
  6. Presence of measurable lesions.

  7. Meeting any of the following criteria:

    1. B symptoms: unexplained fever >38°C, night sweats, unexplained weight loss >10% in the last 6 months.
    2. Abnormal signs: splenomegaly, pleural effusion, ascites, etc.
    3. Major organ damage: involvement of major organs leading to organ dysfunction.
    4. Hematologic involvement: cytopenia [WBC < 1.0 × 10⁹/L and/or PLT < 100 × 10⁹/L]; leukemia-like manifestations (malignant cells > 5.0 × 10⁹/L); elevated LDH levels; HGB < 120 g/L; β2-microglobulin ≥ 3 mg/L.
    5. Bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for Ann Arbor stage III-IV patients).
    6. Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  9. Expected survival of > 6 months.

Exclusion Criteria:

  1. History of allergy to any component of monoclonal antibodies or investigational drugs.
  2. Central nervous system involvement.
  3. History of previous malignant tumors.
  4. Clinically significant cardiac or pulmonary diseases.
  5. Infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment.
  6. Major surgery within 4 weeks prior to enrollment.
  7. Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study.
  8. HIV antibody positive.
  9. Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.
  10. Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
  11. Pregnant or breastfeeding women, or planning to become pregnant during the study.
  12. Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zuberitamab and Bendamustine Combination Treatment

Induction therapy:

  1. Zuberitamab: 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6).
  2. Bendamustine: 90 mg/m², administered on D1-2 of C1-C6. Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) or partial remission (PR) will continue with maintenance therapy.

Maintenance therapy:

Zuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses).
Drug: Zuberitamab
375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6)
Drug: Bendamustine
90 mg/m², administered on D1-2 of C1-C6

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete Response (CR)
Time Frame: Up to 6 cycles (each cycle is 28 days).
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
Up to 6 cycles (each cycle is 28 days).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 6 cycles (each cycle is 28 days).
The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.
Up to 6 cycles (each cycle is 28 days).
Progression-Free Survival (PFS)
Time Frame: From the start of induction therapy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 78 months.
The length of time during and after treatment that a patient lives with cancer without it getting worse or progressing.
From the start of induction therapy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 78 months.
Event-Free Survival (EFS)
Time Frame: From the start of induction therapy to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason, whichever occurs first, assessed up to 78 months.
The length of time during and after treatment during which a patient remains free from any of the following events: disease progression, treatment discontinuation for any reason, or death from any cause.
From the start of induction therapy to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason, whichever occurs first, assessed up to 78 months.
Duration of Response (DOR)
Time Frame: From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.
The length of time during and after treatment that a patient's disease remains under control or in remission. It is the period from the first documentation of a response (such as partial or complete remission) until disease progression or relapse occurs.
From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.
Overall Survival (OS)
Time Frame: From the start of induction therapy to death from any cause, assessed up to 78 months.
The length of time from the date of enrollment until death from any cause.
From the start of induction therapy to death from any cause, assessed up to 78 months.
Time to Next Treatment (TTNT)
Time Frame: From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.
The length of time from the initiation of a current treatment until the patient requires a subsequent line of therapy for the cancer.
From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
Time Frame: From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.
The occurrence and intensity of undesirable or harmful effects experienced by patients associated with the use of a medical treatment or intervention during the clinical trial.
From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fifth Affiliated Hospital, Sun Yat-Sen University
Gansu Cancer Hospital
Fifth Affiliated Hospital of Guangzhou Medical University
Ganzhou Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2024-815-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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